Iron Status in Women of Reproductive Age Reproductive Age

Iron Metabolism Disorders Clinical Trial

Official title:

Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276247
• Other study ID #: HEIRS-womenrepage
• Status: Completed
• Phase: N/A
• First received: September 1, 2017
• Last updated: September 7, 2017
• Start date: January 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2017
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in the United States and Canada using de-identified data from the HEIRS study.

Description:

HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting. Participants were recruited from four centers in the U.S .and one in Canada from February 2001 to February 2003. We will evaluate results for women aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) SF concentration > 300 μg/L and 2) SF >200 μg/L in combination with TSAT >45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22042
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Gender: Female
• Age group: 25 Years to 44 Years

Eligibility

Inclusion Criteria:

1. primary care women included in the HEIRS study with in the age range of this study

2. Self designation as Asian American, African American, Hispanic American or White.

Exclusion Criteria:

1. Age >44 years

2. Self-described ethnicity other in than inclusion criterion 2.

Related Conditions & MeSH terms

• Iron Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Victor Gordeuk	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevated serum ferritin	Serum ferritin >300 ug/L	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Primary	Elevated serum ferritin and transferrin saturation	Serum ferritin >200 ug/L and transferrin saturation >45%	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Primary	Iron deficiency	Serum ferritin <15ug/L	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.